SUPPLEMENT DEA Amides Crosslinked Alkyl Acrylates DEA Formaldehyde Silylates CIR ...

95 Pages·2011·2.49 MB·English

SUPPLEMENT

DEA Amides
Crosslinked Alkyl Acrylates
DEA
Formaldehyde
Silylates

CIR EXPERT PANEL MEETING
SEPTEMBER 26-27, 2011
DEA Amides
Memorandum

To: CIR Expert Panel Members and Liaisons

From: Monice M. Fiume MMF
Senior Scientific Analyst/Writer

Date: September 16, 2011

Subject: Wave 2 memo - Diethanolamides

Updated concentration of use data were received for the diethanolamides. The only new information is
that Lauramide DEA is used in ‘other shaving preparations’ at 0.7%. This does not have an impact on
the use tables.

These data are included with this Wave 2 memo.
Personal Care iProducts Council
Committed to Safety,
Quality & Innovation
Memorandum
TO: F. Alan Andersen, Ph.D.
Director COSMETIC INGREDIENT REVIEW (OR)
-
FROM: Halyna Breslawec, Ph.D.
Industry Liaison to the C]R Expert Panel
DATE: September 14, 2011
SUBJECT: Updated Concentration of Use Information by FDA Product Category: Dialkanolamides
110117th Street, N.W., Suite 300 Washington, D.C. 20036-4702 202.331.1770 202.331.1969 (fax) www.personalcarecouncil.org
Concentration ofUse by FDA Product Category
Cocamide DEA Lanolinamide DEA Ricinoleamide DEA
Almondamide DEA Lauramide DEA Sesamide DEA
Apricotamide DEA Lauramide/Myristamide DEA Shea Butteramide/Castoramide
Avocadamide DEA Lecithinarnide DEA DEA
Babassuamide DEA Linoleanilde DEA Soyamide DEA
Behenamide DEA Minkamide DEA Stearamide DEA
Capramide DEA MyristamideDEA Stearamide DEA-Distearate
Cocoyl Sarcosinamide DEA Oleamide DEA Stearamidoethyl Diethanolamine
CornamideDEA Palm KernelamideDEA Stearamidoethyl Diethanolamine
Cornamide/Cocamide DEA Palmamide DEA HO
DEA-Cocoamphodipropionate Palmitamide DEA Tallamide DEA
Diethanolaminooleamide DEA PEG-2 Tallowamide DEA Tallowamide DEA
Hydrogenated Tallowamide DEA PEG-3 Cocamide DEA UndecylenamideDEA
IsostearamideDEA Ricebranamide DEA Wheat Germamide DEA*
Lactamide DEA
Ingredient ProductCategory Concentration of
Use
Cocamide DEA Baby shampoos 2%
Cocamide DEA Bath oils, tablets and salts 3-6%
Cocamide DEA Other bath preparations 0.4%
Cocamide DEA Shampoos (noncoloring) 1-7%
Cocamide DEA Bath soaps and detergents 2-3%
Cocamide DEA Other personal cleanlinessp1roducts 3%
Cocamide DEA Shaving cream (aerosol, brushless and lather) 3%
Cocamide DEA Skin cleansing (cold creams, cleansing lotions, 6%
liquids and pads)
CocamideDEA Face and neckcreams, lotions and powders 1%
Cocamide DEA Body and hand creams, lotions and powders 0.5-2%
Cocamide DEA Paste masks and mud packs 0.5%
LauramideDEA Bubble baths 2-8%
LauramideDEA Hair sprays (aerosol fixatives) 0.3%
LauramideDEA Shampoos (noncoloring) 2-8%
Lauramide DEA Tonics, dressings and other hair grooming aids 0.3-6%
Lauramide DEA Wave sets 0.4%
Lauramide DEA Hair tints 0.2%
Page 1 of 2
Lauramide DEA Bath soaps and detergents 4-5%
Lauramide DEA Deodorants (underarm) 2%
Lauramide DEA Feminine hygiene deodorants 02%
Lauramide DEA Other personal cleanliness p2roducts 2-4%
Lauramide DEA Shaving cream (aerosol, brushless and lather) 1%
Lauramide DEA Other shavingpreparation 0.7%
Lauramide DEA Skin cleansing (cold creams, cleansing lotions, 3-5%
liquids and pads)
Lauramide DEA Foot powders and sprays 9%
Linoleamide DEA Bubblebaths 3%
LinoleamideDEA Hair conditioners 3%
Linoleamide DEA Shampoos (noncoloring) 7%
Linoleamide DEA Hair dyes and colors (all types requiring caution 7-12%
statement and patch test)
Linoleamide DEA Bath soaps and detergents 7%
Linoleamide DEA Shaving cream (aerosol brushless and lather) 1%
Myristamide DEA Bath soaps and detergents 0.8%
OleamideDEA Hair dyes and colors (all types requiring caution 5%
statementand patch test)
PalmKernelamide DEA Shampoos (noncoloring) 2%
Palm Kernelamide DEA Other hairpreparations (3noncoloring) 2%
Stearamide DEA Wave sets 0.5%
Stearamidoethyl Diethanolamine Other bath preparations 0.5%
*Ingredients found in the title ofthe table but notfound in the table were included in the concentration ofuse survey,
butno uses were reported.
13% in a liquid body soap and in a shower cream
224% in shower gel, body wash products
2% in a rinse-offscalp massaging tonic
Informationcollected in 2011
Table prepared March 14, 2011
Updated May 16, 2011
Cocamide DEA: added low concentration Bath oils, tablets and salts; addedcategories: Other bath preparations and
Paste masks and mudpacks; Linoleamide DEA: added high concentrations Hair dyes and colors; Oleamide DEA:
added ingredient
Updated August 9, 2011 CocamideDEA: Bath soaps and detergents: maximum concentration reduced to 3%;
Lauramide DEA: Hair sprays 0.4% product removed; Bath soaps and detergents 3% product removed
Updated September 9, 2011 Lauramide DEA added other shaving preparation
Page2 of 2
Crosslinked Alkyl Acrylates
Memorandum

To: CIR Expert Panel Members and Liaisons
From: Monice M. Fiume MMF
Senior Scientific Analyst/Writer
Date: September 16, 2011
Subject: Wave 2: Risk Assessment for Acrylates/C10-30 Alkyl Acrylates Crosspolymer

As promised in the transmittal memo for the supplement to the Crosslinked Alkyl Acrylates
report, the CIR has analyzed the “benzene impurity in Acrylates/C10-30 Acrylate Crosspolymer
risk assessment” that was received from the CIR Science and Support (SSC) on August 19.
(This supplement should have been included in your Panel book, and is also being included with
this submission.)

The document that follows presents the CIR SSC interpretation of the risk assessment findings,
as well as an interpretation by Dr. Boyer.

Additionally, it was promised that the CIR would research existing safety assessments to find
those that have addressed benzene. In addition to the Carbomers, which is referenced in the CIR
SSC memo, only Toluene (JACT 6(1) 1987) discussed limits for benzene, stating in the Discus-
sion that cosmetic products formulated with toluene should be benzene-free.

The other mentions of benzene in CIR safety assessments are in the ‘Method of Manufacture’
section of three reports. Maleic acid is manufactured by the oxidation of benzene. Hydro-
quinone is produced by alkylation of benzene and propylene to produce a mixture of di-iso-
propylbenzene isomers, followed by the isolation of the p-isomer which is oxidized with oxygen
to produce the corresponding dihydroperoxide and then treated with acid to produce acetone and
hydroquinone. Pyrocatechol is manufactured by the oxidation of benzene with hydrogen
peroxide. There is no other discussion of benzene in those reports.

The CIR write-up and analysis of the CIR SSC data, updated concentration of use tables, the
memo from the CIR SSC, and Dr. Boyer’s risk assessment follow.
RISK ASSESSMENT
BENZENE IN ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER
At the June 2011 meeting, the Expert Panel determined that the data were insufficient for the Panel to conclude that
Acrylates/C10-30 Alkyl Acrylates Crosspolymer polymerized in benzene would be safe for use in cosmetics, and the need for
a risk assessment before a safe level could be determined was discussed.
In response, the CIR Science and Support Committee (SSC) submitted an example risk assessment of Acryl-
ates/C10-30 Alkyl Acrylates Crosspolymer polymerized in benzene as used in cosmetics.1 Additionally, updated concen-
tration of use data were submitted. These data indicate that the highest leave-on concentration of use of Acrylates/C10-30
Alkyl Acrylates Crosspolymer, polymerized in benzene, is 0.4%. Therefore, this is the concentration used to estimate expo-
sure. The SSC assumed 0.41% as the concentration of benzene in raw materials, because this was the highest concentration
of benzene measured in 40 batches of Acrylates/C10-30 Alkyl Acrylates Crosspolymer. (However, according to a product
specification sheet, Acrylates/C10-30 Alkyl Acrylate Crosspolymer can contain 0.5% max. residual benzene.) The SSC also
used 7.63 g as the 50the percentile amount of body lotion applied per day and 16.83 g as the 95th percentile amount applied per
day, per Loretz et al. (2005).2 Additionally, based on a discussion with Dr. Robert Bronaugh, an estimated dermal penetra-
tion factor of 10% was assumed. Although it has been shown that approximately 0.2% of 400 to 500 µl neat benzene applied
to skin absorbs, with most of the applied dose evaporating within 30 seconds,3 the potential for dermal penetration of benzene
may increase when in a cosmetic product due to decreased evaporation from the skin and a corresponding increase in the dur-
ation of skin contact.
The SSC then compared the estimated exposure to benzene from Acrylates/C10-30 Alkyl Acrylates Crosspolymer
as used in lotion to the daily exposure range corresponding to the Environmental Protection Agency (EPA) concentrations
representing a 10-6 risk for cancer from benzene in drinking water.4 The SSC stated that the estimated exposure from the use
of a leave-on body product at the 50th percentile, using the assumptions outlined above, are within the EPA 10-6 risk level,
and that use at the 95th percentile is just above the 10-6 level. According to calculations by Dr. Boyer, the 50th percentile ex-
posure estimate is within the EPA drinking water exposure range representing a 10-6 risk, but the 95th percentile exposure
estimate exceeds this range by about 38%.
The SSC then added another assumption based on their thoughts that “significant volatilization of benzene” would
occur during the manufacture of the finished product, i.e., the lotion. For their calculations, the SSC assumed 10% volatiliza-
tion of the residual benzene during the manufacturing process. Using this assumption, the SSC stated that exposure to the
body lotion at the 95th percentile is within the EPA 10-6 risk level. According to Dr. Boyer’s calculations, with 10% of the
benzene volatilized, the daily exposure range representing 10-6 risk is still exceeded by 24% at the 95th percentile exposure
level.
The CIR reviewed the assumptions put forth by the SSC, and performed its own risk assessment. During internal
CIR discussions of the SSC risk assessment, Dr. Heldreth noted that he did not think it could be predicted with certainty what
quantity of benzene would be volatilized/leached from Acrylates/C10-30 Alkyl Acrylates Crosspolymer during manufacture,
formulation, or product use. While some benzene is inevitably volatilized during manufacture, some benzene may be trapped
in the polymer matrix and may leach out during formulation and use, but there was no way of knowing how much (or if any)
benzene would leach out without appropriate data from a representative product formulation. Dr. Boyer was concerned that
more reliable values were not available to estimate the amount of benzene volatilized from Acrylates/C10-30 Alkyl Acrylates
Crosspolymer during the manufacture of a finished product or for the absorption of benzene from a finished product contain-
ing Acrylates/C10-30 Alkyl Acrylates Crosspolymer. Dr. Boyer performed his own risk assessment calculations using the
SSC assumptions and the two EPA slope factors for benzene, assuming a 70 kg person and life-long daily exposure.
Using the two EPA slope factors, the risk estimates for the 95th percentile usage of body lotion, assuming 10%
volatilization and 10% skin absorption, ranged from 5.3 x 10-6 to 2.0 x 10-5. For 50th percentile usage and these same as-
sumptions, the risk estimates ranged from 2.4 x 10-6 to 8.9 x 10-6.
Dr. Boyer then examined the effect of assuming 0% volatilized benzene on the risk estimates, still assuming 10%
penetration of benzene through the skin. With no benzene volatilized during product manufacturing or use, the risk estimates
ranged from 5.9 x 10-6 to 2.2 x 10-5 for 95th percentile exposure and from 2.7 x 10-6 to 9.8 x 10-6 for 50th percentile exposure.
Additionally, since the supplier specification sheet states that up to 0.5% residual benzene can exist in Acrylates/
C10-30 Alkyl Acrylates Crosspolymer, the risk assessment calculations were performed assuming 0.5% residual benzene in
the raw material, as opposed to 0.41% residual benzene. With 10% benzene assumed to be volatilized during the manufac-
ture of the finished product, the risk estimates ranged from 6.5 x 10-6 to 2.4 x 10-5 for 95th percentile exposure and from 2.9 x
10-6 to 1.1 x 10-5 for 50th percentile exposure. With no benzene volatilized, this range was 7.2 x 10-6 to 2.7 x 10-5 for 95th
percentile exposure and from 3.3 x 10-6 to 1.2 x 10-5 for 50th percentile exposure.
All of these risk estimates are greater than 10-6. Further calculations by Dr. Boyer determined that to get to a risk
estimate of 10-6 at the 95th percentile exposure level, assuming 10% percutaneous absorption and 0.41% residual benzene, us-
ing the highest cancer slope factor, about 95% of the benzene would need to evaporate during the manufacturing process;
with the lowest slope factor, the evaporation of benzene would need to be about 83%. For the 50th percentile exposure level,
with all other assumptions as just described, about 89% of the benzene would need to evaporate for a 10-6 risk estimate using
the highest EPA slope factor, and about 63% evaporation would be needed using the lowest slope factor.

1. Personal Care Products Council. 2011. Benzene Impurity in Acrylates/C10-30 Alkyl Acrylates Crosspolymer: Risk
Assessment and Updated Concentration of Use Table. 21 pages.
2. Loretz LJ, Api AM, Barra j LM, and et al. Exposure data for cosmetic products: lipstick, body lotion, and face cream.
Food Chem Toxicol. 2005;43:279-291.
3. Franz TJ. Percutaneous absorption of benzene. Chapter: 5. MacFarland HN, Holdsworth CE, MacGregor JA, Call RW,
and Lane ML.In: Advances in Modern Environmental Toxicology. Volume VI. Applied Toxicology of
Petroleum Hydrocarbons. Princeton, NJ: Princeton Scientific Publishers, Inc; 1984:61-70.
4. Environmental Protection Agency (EPA). IRIS summary for benzene. Last revised 1/19/2000.
http://www.epa.gov/iris/subst/0276.htm. 2002.